250 mg hard capsules
Saccharomyces boulardii strain CNCM I-745 (lyophilized)

What Precosa is and what it is used for

Precosa consists of a yeast fungus (Saccharomyces boulardii) in a freeze-dried form that prevents harmful effects of disease-causing bacteria on the intestinal mucosa.

Precosa capsule is used to prevent antibiotic-associated diarrhea in adults and children over 6 years of age.

What you need to know before using Precosa

Do not use Precosa

  • if you are allergic to Saccharomyces boulardii or yeast or any of the other ingredients of this medicine (listed in section 6).
  • if you have a central venous catheter implanted.
  • if you have a weakened immune system or if you are hospitalized (due to a serious illness or altered/weakened immune system).

Warnings and cautions

Contact a doctor if

– you get severe diarrhea that does not improve after 2-3 days despite treatment with Precosa.

– you have a fever.

– you have bloody or slimy stools.

– you are very thirsty or have a dry mouth: these symptoms indicate dehydration (caused by diarrhea).

Children

Precosa capsules should not be given to children under 6 years of age without a doctor’s prescription.

Other medicines and Precosa

The effect of the treatment can be affected if Precosa is used at the same time with certain antifungal agents. Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Pregnancy and breastfeeding

Saccharomyces boulardii passes through the intestine without being absorbed into the body and can therefore not affect the fetus.

Saccharomyces boulardii is not excreted in human milk.

Driving and using machines

Precosa does not affect your ability to drive or use machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Precosa contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

How to use Precosa

Always use this medicine as described in this leaflet or as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Treatment should be started within 48 – 72 hours after the first intake of antibiotics and continue for at least 3 days after the end of antibiotic treatment but for a maximum of 4 weeks.

The recommended dose is:

Adults

2 capsules in the morning and 2 capsules in the evening.

Children from 6 years up to 18 years

1 capsule in the morning and 1 capsule in the evening.

If you take more Precosa than you should

If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.

If you forget to take Precosa

Do not take a double dose to make up for a forgotten dose.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Precosa and contact your doctor immediately if you get any of the following symptoms ( angioedema ):

Rare (may affect up to 1 in 1,000 people):

  • swelling of the face, tongue, or throat,
  • difficulty swallowing,
  • hives and difficulty breathing.

Other side effects:

Uncommon (may affect up to 1 in 100 people): allergic reactions, hives, constipation, thirst.

Rare (may affect up to 1 in 1,000 people): skin changes.

Very rare (may affect up to 1 in 10,000 people): the presence of yeast in the blood (fungemia).

No known frequency (can not be calculated from the available data): severe blood infection ( sepsis ).

In some patients with severe generalized impairment, cases of blood poisoning ( sepsis ) with Saccharomyces boulardii have occurred.

How to store Precosa

Keep out of sight and reach of children.

Do not store above 25 ° C. Close the package tightly. Moisture sensitive.

Do not use this medicine after the expiry date which is stated on the carton. The expiration date is the last day of the specified month.

The medicine should not be disposed of via wastewater or household waste. Ask at the pharmacy how to dispose of medicines no longer required. These measures will help to protect the environment.

Contents of the pack and other information

Content declaration

  • The active substance is Saccharomyces boulardii strain CNCM I-745 (lyophilized) 250 mg.
  • Other excipients are lactose monohydrate, magnesium stearate, gelatin, and titanium dioxide (dye E 171).

What the medicine looks like and the contents of the pack

Precosa hard capsule is a white gelatin capsule.

The package contains 10, 20, or 50 capsules in a glass jar or 30 capsules in a blister (Al / PVC ‑ Al / PVC / PVDC).

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Holder of a marketing authorization

Biocodex

7, Avenue Gallieni

F-94250 Gentilly

France

Manufacturer

Biocodex

Beauvais

France

Information is provided by

Biocodex AB

Coffin

info@biocodex.se

Muhammad Nadeem

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